Post-Launch Product R&D Expenses definition

Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4 clinical trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance), in each case that are (a) specifically attributable to a ZIOPHARM Product in the countries of the Territory where such ZIOPHARM Product has been launched and (b) approved by both Parties in writing.
Sample 1Sample 2Sample 3
Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Licensed Product after the first commercial launch and shall exclude administrative expenses and costs that are included within Costs of Goods or Development Costs. Such post-launch research and development costs shall include the following expenses only if such expenses are directly attributable to a Licensed Product:
Sample 1Sample 2Sample 3
Post-Launch Product R&D Expenses shall have the meaning set forth in Exhibit A.
Sample 1Sample 2

Examples of Post-Launch Product R&D Expenses in a sentence

  • Product and specifically attributable to the Commercialization of such ZIOPHARM Product: (a) Cost of Goods Sold, (b) Marketing Expenses, (c) Distribution Expenses, (d) Post-Launch Product R&D Expenses, and (e) Additional Commercialization Expenses, in each case as such terms are defined and calculated in this Article 1 and in Exhibit A.


More Definitions of Post-Launch Product R&D Expenses

Post-Launch Product R&D Expenses means the costs of Phase IV -------------------------------- Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance) which are specifically attributable to a Collaboration Product in the Co-Promotion Territory where such Collaboration Product has been launched, excluding costs that are included within Costs of Goods Sold or Development Expenses. Post- Launch Product R&D Expenses shall be calculated in the manner set forth in Exhibit A.
Sample 1Sample 2
Post-Launch Product R&D Expenses means certain research and development costs incurred by a Party in relation to a Collaboration Product for the Shared Territory in the Field after the First Commercial Sale in the Shared Territory of such Collaboration Product and required to obtain or maintain a Regulatory Approval in the Shared Territory. Such post-launch research and development costs shall include Phase IV Clinical Trials and ongoing medical affairs.
Sample 1Sample 2
Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4
Sample 1
Post-Launch Product R&D Expenses means the costs of Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product
Sample 1
Post-Launch Product R&D Expenses means the following research and development costs and expenses, including the cost of FTEs, incurred or accrued (as applicable in accordance with Article 1 of this Financial Appendix) by a Party in direct relation to a Collaboration Product after the first commercial launch of a Collaboration Product: Phase 4 Trials, ongoing Collaboration Product support, ongoing medical affairs (meaning pharmacoeconomic studies, outcomes studies and extramural studies), preclinical research (including without limitation investigation of additional therapeutic uses), and fees and expenses of outside counsel in respect of regulatory affairs unrelated to obtaining Regulatory Approvals.
Sample 1
Post-Launch Product R&D Expenses means the costs of Phase IIIB Clinical ---------------------------------- Trials and Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support safety and surveillance necessary for product maintenance) which are specifically attributable to a Collaboration Product in the Profit/Loss Sharing Territory where such Collaboration Product has been launched, excluding costs that are included within Costs of Goods Sold or Development Expenses and any costs reasonably associated with maintaining Regulatory Approval of Collaboration Compounds and Products. Post-Launch Product R&D Expenses shall be calculated in the manner set forth in Exhibit A. Notwithstanding the foregoing, with respect to Phase IIIB Clinical Trials for Bromocriptine specifically identified in Exhibit E, the costs of such trials shall not be a Post-Launch Product R&D Expense, but shall instead be treated as a Development Expense for the purposes of this Agreement, but ORTHO may elect for its internal purposes to treat such expenses as commercialization expenses.
Sample 1

Related to Post-Launch Product R&D Expenses

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • Patent Expenses means all reasonable costs (including attorneys’ and application fees) incurred by University in accordance with this Agreement to apply for, prosecute and maintain Licensed Patents, including but not limited to the costs of interferences, oppositions, inter partes review and re-examinations. Patent Expenses include reimbursement for in-house costs provided they are for activities that would otherwise have been performed by outside counsel at an equal or greater expense.

  • Program Costs means all necessary and incidental costs of providing program services.

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Back Ordered Products If product is not expected to ship within the time provided to the TIPS Member by the Vendor, the Member is to be notified within 3 business days and appropriate action taken based on customer request. The TIPS Vendor Agreement Signature Page is inserted here.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Terminated Product has the meaning set forth in Section 18.3.4.2(v).

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • WTO GPA country end product means an article that—

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Development Plan has the meaning set forth in Section 3.2.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Milestone Payments has the meaning set forth in Section 4.2.